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UA87836C2 - METHOD OF OBTAINING PURE, SAFETY FROM THE VIRUSOLOGICAL POINT OF VIEW OF ANTIBODIES - Google Patents

METHOD OF OBTAINING PURE, SAFETY FROM THE VIRUSOLOGICAL POINT OF VIEW OF ANTIBODIES

Info

Publication number
UA87836C2
UA87836C2 UAA200610282A UAA200610282A UA87836C2 UA 87836 C2 UA87836 C2 UA 87836C2 UA A200610282 A UAA200610282 A UA A200610282A UA A200610282 A UAA200610282 A UA A200610282A UA 87836 C2 UA87836 C2 UA 87836C2
Authority
UA
Ukraine
Prior art keywords
solution
antibodies
virus
resin
heplanoale
Prior art date
Application number
UAA200610282A
Other languages
Russian (ru)
Ukrainian (uk)
Inventor
Андреа Бухахер
Гюнтер Иберер
Юрген Рьёмиш
Original Assignee
Октафарма Аг
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34910983&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=UA87836(C2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Октафарма Аг filed Critical Октафарма Аг
Publication of UA87836C2 publication Critical patent/UA87836C2/en

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/022Filtration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04Heat
    • A61L2103/05

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

A method of preparing a purified, virus inactivated and virus safe antibody preparation from a starling solution comprising antibodies and contaminants, the method comprising the steps of: (a) adjusting the pH of the starting solution to about 4.6 to about 4-95 in particular to about 4.8 to about 4.95 to produce an intermediate solution; (b) adding caprylale and/or heplanoale ions to the intermediate solution and maintaining the pH at about 4.6 to about 4.95 in particular pH at about 4.8 to about 4.95, whereby a precipitate is formed and the antibodies are essentially present in the supernatant; (c) incubating the supematant solution under conditions of caprylale and/or heplanoale ion concentration, lime, pH and temperature optionally concentrating and diafiltrating the filtrated solution before pH adjustment; (d) applying the filtered solution with a least one anion exchange resin and optionally with two different anion exchanae resins under conditions that allow binding of contaminants to the resin while not allowing significant binding' of the antibodies to the resin, wherein a purified, virus inactivated and virus safe antibody preparation is produced.
UAA200610282A 2004-02-27 2005-02-25 METHOD OF OBTAINING PURE, SAFETY FROM THE VIRUSOLOGICAL POINT OF VIEW OF ANTIBODIES UA87836C2 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US54810704P 2004-02-27 2004-02-27

Publications (1)

Publication Number Publication Date
UA87836C2 true UA87836C2 (en) 2009-08-25

Family

ID=34910983

Family Applications (1)

Application Number Title Priority Date Filing Date
UAA200610282A UA87836C2 (en) 2004-02-27 2005-02-25 METHOD OF OBTAINING PURE, SAFETY FROM THE VIRUSOLOGICAL POINT OF VIEW OF ANTIBODIES

Country Status (18)

Country Link
US (1) US7553938B2 (en)
EP (2) EP1718675B2 (en)
JP (1) JP5042817B2 (en)
KR (1) KR101206788B1 (en)
CN (1) CN1922207B (en)
AU (1) AU2005217148B2 (en)
BR (1) BRPI0508096B8 (en)
CA (1) CA2557229C (en)
DK (1) DK1718675T3 (en)
ES (1) ES2407380T5 (en)
IL (1) IL177541A (en)
NO (1) NO20063784L (en)
PL (1) PL1718675T3 (en)
PT (1) PT1718675E (en)
RU (1) RU2337109C2 (en)
UA (1) UA87836C2 (en)
WO (1) WO2005082937A2 (en)
ZA (1) ZA200607119B (en)

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KR20160068972A (en) 2013-11-15 2016-06-15 노파르티스 아게 Removal of residual cell culture impurities
RU2561596C2 (en) * 2013-12-18 2015-08-27 Федеральное государственное унитарное предприятие "Научно-производственное объединение по медицинским иммунобиологическим препаратам "Микроген" Министерства здравоохранения Российской Федерации Method for producing virus-inactivated immunoglobulin solutions low in residual caprylic acid
TWI709570B (en) 2014-01-17 2020-11-11 美商健臻公司 Sterile chromatography and manufacturing processes
TWI709569B (en) 2014-01-17 2020-11-11 美商健臻公司 Sterile chromatography resin and use thereof in manufacturing processes
KR20160118369A (en) * 2014-02-27 2016-10-11 에이전시 포 사이언스, 테크놀로지 앤드 리서치 Antibody purification process
EP3118210B1 (en) * 2014-03-11 2019-11-13 Green Cross Holdings Corporation Method for purifying immunoglobulin
EP3842108A1 (en) * 2014-04-30 2021-06-30 Novo Nordisk A/S Methods for the purification of proteins using caprylic acid
WO2015195452A2 (en) 2014-06-16 2015-12-23 Emd Millipore Corporation Single-pass filtration systems and processes
WO2015195453A2 (en) 2014-06-16 2015-12-23 Emd Millipore Corporation Methods for increasing the capacity of flow-through processes
CN115463546A (en) 2014-06-25 2022-12-13 Emd 密理博公司 Filter element, tangential flow filtration system, method of producing a feed screen
EP3010626B1 (en) 2014-08-29 2022-12-14 EMD Millipore Corporation Processes for filtering liquids using single pass tangential flow filtration systems and tangential flow filtration systems with recirculation of retentate
KR102079585B1 (en) 2014-08-29 2020-02-21 이엠디 밀리포어 코포레이션 Single pass tangential flow filtration systems and tangential flow filtration systems with recirculation of retentate
ES2964640T3 (en) 2015-08-13 2024-04-08 Amgen Inc Depth filtration loaded with antigen-binding proteins
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ES2925059T3 (en) 2016-06-09 2022-10-13 Emd Millipore Corp Radial path filter elements, systems and methods of use thereof
ES2770674T3 (en) 2016-06-10 2020-07-02 Octapharma Ag High concentration immunoglobulin composition for pharmaceutical applications
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DK3510042T3 (en) 2016-09-07 2024-06-10 Glaxosmithkline Ip Dev Ltd Method for purification of antibodies
JP6370853B2 (en) * 2016-09-26 2018-08-08 インスティトゥト グリフォルス,ソシエダ アノニマ Method for preparing immunoglobulin
RU2708394C2 (en) * 2016-09-26 2019-12-06 Институто Грифольс,С.А. Method of producing immunoglobulins
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EP3843869A1 (en) 2018-08-31 2021-07-07 Genzyme Corporation Sterile chromatography resin and use thereof in manufacturing processes
CN110627892B (en) * 2019-09-05 2023-04-14 江苏康禾生物制药有限公司 Preparation method of recombinant human thrombopoietic factor stock solution
CN110590931B (en) * 2019-09-05 2023-04-07 江苏康禾生物制药有限公司 Method for removing and/or inactivating virus in recombinant human thrombopoietin stock solution
MX2022011950A (en) 2020-03-31 2022-10-21 Takeda Pharmaceuticals Co METHOD FOR PRODUCING AN IMMUNOGLOBULIN PREPARATION FROM PLASMA WITH REDUCTION OF THE C-1 INHIBITOR.
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JP7606185B2 (en) * 2020-09-03 2024-12-25 日機装株式会社 Phenol red adsorbent and method for removing phenol red
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Also Published As

Publication number Publication date
AU2005217148A1 (en) 2005-09-09
EP1718675B2 (en) 2017-01-25
IL177541A0 (en) 2006-12-10
DK1718675T3 (en) 2013-07-15
BRPI0508096B8 (en) 2021-05-25
EP1718675A2 (en) 2006-11-08
PT1718675E (en) 2013-05-21
KR101206788B1 (en) 2012-11-30
PL1718675T3 (en) 2013-09-30
IL177541A (en) 2014-09-30
NO20063784L (en) 2006-09-25
WO2005082937A3 (en) 2005-11-17
CA2557229A1 (en) 2005-09-09
JP5042817B2 (en) 2012-10-03
EP2277915A1 (en) 2011-01-26
ES2407380T3 (en) 2013-06-12
CA2557229C (en) 2012-07-10
AU2005217148B2 (en) 2011-09-08
KR20060131920A (en) 2006-12-20
CN1922207B (en) 2012-06-06
RU2337109C2 (en) 2008-10-27
BRPI0508096A (en) 2007-07-17
CN1922207A (en) 2007-02-28
RU2006134285A (en) 2008-04-10
WO2005082937A2 (en) 2005-09-09
JP2007533660A (en) 2007-11-22
BRPI0508096B1 (en) 2019-04-02
US20070173638A1 (en) 2007-07-26
US7553938B2 (en) 2009-06-30
EP1718675B1 (en) 2013-04-10
ZA200607119B (en) 2007-04-25
ES2407380T5 (en) 2017-07-07

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